Portable Oxygen Concentrator P2-E6
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- PORTABLE OXYGEN CONCENTRATOR EUDAMEDRhythm Healthcare FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Portable Oxygen Concentrator EUDAMED
- Model / Reference
- P2-S4 EUDAMEDFDA UDIP2-K3 P2-K4 P2-S3 P2-S4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971882890482 EUDAMED06971882890239 FDA UDI
- Basic UDI-DI
- 697188289P2-K/SKK EUDAMED
- Direct Marketing DI
- 06971882890482 EUDAMED
- FDA Product Code
- CAW FDA 510(k)FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5440 FDA 510(k)
- Regulation Number
- 868.5440 FDA 510(k)FDA UDI
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Portable Oxygen Concentrator P2-E6 is a medical device classified as a Generator, Oxygen, Portable, designed to concentrate ambient air and deliver high-flow oxygen therapy. It operates by filtering and compressing atmospheric air to produce oxygen-enriched gas, suitable for patients requiring supplemental oxygen in ambulatory or home settings.
This device is intended for single-use or reusable applications, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance, MDD, and MDR compliance. It is supplied as a non-sterile, Class II medical device, with no specific MRI safety restrictions noted. The device is available in a single model configuration (P2-E6) and must be stored in accordance with manufacturer instructions to maintain functionality and safety.
Frequently asked questions
What is the primary purpose of the Portable Oxygen Concentrator P2-E6, and where is it typically used?
The Portable Oxygen Concentrator P2-E6 is designed to concentrate ambient air and deliver high-flow oxygen therapy. It is intended for patients requiring supplemental oxygen in ambulatory or home settings, allowing them to maintain mobility while receiving treatment.
Is the P2-E6 device single-use or reusable, and how does this affect its use?
The P2-E6 can be used for either single-use or reusable applications, depending on the manufacturer’s guidelines. This flexibility allows healthcare providers to choose the most appropriate use case based on clinical needs, infection control protocols, and cost considerations.
What are the key regulatory approvals for the P2-E6, and how does this impact its availability?
The P2-E6 holds FDA 510(k) clearance, MDD, and MDR compliance, confirming its regulatory status in the U.S. and EU markets. These approvals ensure it meets safety and performance standards, allowing it to be legally marketed and distributed in jurisdictions where these certifications are recognized.
Is the P2-E6 sterile, and what storage instructions should be followed to maintain its functionality?
The P2-E6 is supplied as a non-sterile device, meaning it is not pre-sterilized for direct patient use. To maintain functionality and safety, it must be stored according to the manufacturer’s instructions, which likely include protection from dust, moisture, and extreme temperatures.
Are there different models or sizes available for the P2-E6, or is it offered in a single configuration?
The P2-E6 is available exclusively in a single model configuration, meaning there are no variations in size, capacity, or features. This standardized design ensures consistency in performance and regulatory compliance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K210371 | Class II | Active |
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Manufacturer
- FDA Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd.
Sources (3)
- FDA 510(k) K210371 24 fields · synced Oct 6, 2026
- FDA UDI 7209d6c6-17d2-423b-a000-409c877d75f5 33 fields · synced May 22, 2026
- EUDAMED d1d960f8-08a7-4b9d-bd8a-d31c3f9eedf0 61 fields · synced Jul 21, 2026